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FDA 510(k)

Advisor VL Circular Mapping Catheter, Sensor Enabled

K-Number: K192037 · 2019-09-17

Decision Date2019-09-17
Product CodeDRF
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Advisor VL Circular Mapping Catheter, Sensor Enabled is a medical device manufactured by ABBOTT MEDICAL. It received FDA 510(k) clearance on 2019-09-17 under approval number K192037. The device is classified under product code DRF. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Advisor VL Circular Mapping Catheter, Sensor Enabled?

Advisor VL Circular Mapping Catheter, Sensor Enabled is a medical device that received FDA 510(k) clearance on 2019-09-17. It is manufactured by ABBOTT MEDICAL. The 510(k) number is K192037.

When was Advisor VL Circular Mapping Catheter, Sensor Enabled approved by the FDA?

Advisor VL Circular Mapping Catheter, Sensor Enabled received FDA 510(k) clearance on 2019-09-17, under approval number K192037.

What company makes Advisor VL Circular Mapping Catheter, Sensor Enabled?

Advisor VL Circular Mapping Catheter, Sensor Enabled is manufactured by ABBOTT MEDICAL.

What is the FDA product code for Advisor VL Circular Mapping Catheter, Sensor Enabled?

The FDA product code for Advisor VL Circular Mapping Catheter, Sensor Enabled is DRF.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.